For shorter or longer durations of
action, smaller or larger maintenance doses may be administered

NOTE: In patients with clinically significant cardiovascular
disease and in patients with any history suggesting a greater
sensitivity to the release of histamine or other mediators, the
initial dose of MIVACRON should be 0.15 mg/kg or less, administered
over 60 seconds.

Safety Considerations1

It is recommended that a peripheral nerve stimulator be used during
the administration of MIVACRON to monitor drug effect, determine the
need for additional drug, and confirm recovery from neuromuscular
block. MIVACRON has no known effect on consciousness, pain
threshold, or cerebration.

INDICATION AND IMPORTANT SAFETY INFORMATION
for MIVACRON® (mivacurium chloride)

INDICATION1

MIVACRON®
(mivacurium chloride) injection is a short-acting neuromuscular
blocking agent indicated for inpatients and outpatients, as an
adjunct to general anesthesia, to facilitate tracheal intubation and
to provide skeletal muscle relaxation during surgery or mechanical
ventilation.

IMPORTANT SAFETY INFORMATION1

MIVACRON is contraindicated
in patients with known hypersensitivity to the product and its
components.

Severe anaphylactic reactions to neuromuscular
blocking agents, including MIVACRON, have been reported. These
reactions have in some cases been life-threatening and fatal.
Necessary precautions, including the immediate availability of
appropriate emergency treatment, should be taken. Precautions should
also be taken in individuals who have had previous anaphylactic
reactions to other neuromuscular blocking agents.

MIVACRON should only be administered intravenously in carefully
adjusted dosage by or under the supervision of experienced
clinicians who are familiar with the drug’s actions and the
possible complications.

It is recommended that a peripheral nerve stimulator be used
during the administration of MIVACRON to monitor drug effect,
determine the need for additional drug, and confirm recovery from
neuromuscular block.

MIVACRON has no known effect on consciousness, pain threshold, or
cerebration.

MIVACRON is metabolized by plasma cholinesterase and should be
used with great caution, if at all, in patients suspected of being
homozygous for the atypical plasma cholinesterase gene due to the
possibility of prolonged neuromuscular block. Plasma
cholinesterase activity may be diminished in patients with genetic
abnormalities of plasma cholinesterase, pregnancy, liver or kidney
disease, malignant tumors, infections, burns, anemia, decompensated
heart disease, peptic ulcer, or myxedema. The neuromuscular blocking
effect of MIVACRON may be enhanced by drugs that reduce plasma
cholinesterase activity (e.g., chronically administered oral
contraceptives, glucocorticoids, or certain monoamine oxidase
inhibitors) or by drugs that irreversibly inhibit plasma
cholinesterase.

Exercise caution when administering MIVACRON
to patients with clinically significant cardiovascular disease,
obesity, or any history suggesting sensitivity to the release of
histamine (e.g., asthma), as a transient decrease in mean arterial
pressure related to histamine release is possible.

MIVACRON
will not counteract the bradycardia produced by many anesthetic
agents or by vagal stimulation.

Doses of MIVACRON should be
individualized for drugs or conditions causing potentiation of or
resistance to neuromuscular block. The following may cause
potentiation: neuromuscular diseases, burns, acid-base and/or serum
electrolyte abnormalities, cachexia, debilitation, and
carcinomatosis. The following may cause resistance: burns, acid-base
and/or serum electrolyte abnormalities, and chronic administration
of phenytoin or carbamazepine.

INDICATION AND IMPORTANT SAFETY INFORMATION
FOR ULTANE® (sevoflurane)

INDICATION3

ULTANE® (sevoflurane) is
indicated for induction and maintenance of general anesthesia in
adult and pediatric patients for inpatient and outpatient surgery.
ULTANE should be administered only by persons trained in the
administration of general anesthesia. Facilities for maintenance of
a patent airway, artificial ventilation, oxygen enrichment, and
circulatory resuscitation must be immediately available. Since level
of anesthesia may be altered rapidly, only vaporizers producing
predictable concentrations of ULTANE should be used.

IMPORTANT SAFETY INFORMATION3

ULTANE can cause malignant
hyperthermia. Postmarketing reports of malignant hyperthermia, some
of which have been fatal, have occurred. ULTANE should not be used
in patients with known sensitivity to sevoflurane or to other
halogenated agents, or in patients with known or suspected
susceptibility to malignant hyperthermia.

Findings taken
from patient and animal studies suggest that there is a potential
for renal injury when ULTANE is used at low flow rates, which is
presumed due to Compound A. The level of Compound A exposure at
which clinical nephrotoxicity might be expected to occur has not
been established. To minimize exposure to Compound A, ULTANE
exposure should not exceed 2 MAC-hours at flow rates of 1 to <2
L/min. Fresh gas flow rates <1 L/min are not recommended.

Because clinical experience in administering ULTANE to patients
with renal insufficiency (creatinine >1.5 mg/dL) is limited, its
safety in these patients has not been established.

ULTANE
may be associated with glycosuria and proteinuria when used for long
procedures at low flow rates.

KOH containing CO2
absorbents are not recommended for use with ULTANE. An exothermic
reaction occurs when ULTANE is exposed to CO2 absorbents.
This reaction is increased when the absorbent becomes desiccated.
Rare cases of extreme heat, smoke, and/or spontaneous fire have been
reported during ULTANE use in conjunction with the use of desiccated
CO2 absorbent, specifically those containing potassium
hydroxide (e.g., Baralyme).

Reports of QT prolongation,
associated with torsade de pointes (in exceptional cases, fatal),
have been received. Caution should be exercised when administering
ULTANE to susceptible patients (e.g. patients with congenital Long
QT Syndrome or patients taking drugs that can prolong the QT
interval).

Rare increases in serum potassium resulting in
cardiac arrhythmias and death have been noted in pediatric patients
during the postoperative period following the use of inhaled
anesthetic agents. Contributing risk factors appear to be latent or
overt neuromuscular disease, particularly Duchenne muscular
dystrophy. Concomitant use of succinylcholine has been associated
with most, but not all, of these cases. Early, aggressive
intervention to treat both hyperkalemia and resistant arrhythmias,
and subsequent evaluation for latent neuromuscular disease, is
recommended.

Studies conducted in young animals and children
suggest repeated or prolonged use of general anesthetic or sedation
drugs in the third trimester of gestation through the first three
years of age may result in adverse cognitive or behavioral effects
on their developing brains. The studies in children have substantial
limitations, and it is not clear if the observed effects are due to
the anesthetic/sedation drug administration or other factors, such
as the surgery or underlying illness. Anesthetic and sedation drugs
are a necessary part of the care of children when needed, and no
specific medications have been shown to be safer than any other.
Decisions regarding the timing of any elective procedures requiring
anesthesia should take into consideration the benefits of the
procedure weighed against the potential risks.

Due to
ULTANE’s insolubility in blood, hemodynamic changes may occur more
rapidly than with other volatile anesthetics. Excessive decreases in
blood pressure or respiratory depression may be related to depth of
anesthesia and may be corrected by decreasing the inspired
concentration of ULTANE.

Seizures have been reported in
association with ULTANE use, the majority of which have occurred in
children and young adults, most of whom had no predisposing risk
factors. Clinical judgment should be exercised when using ULTANE in
patients who may be at risk for seizures.

Drug
interactions: Benzodiazepines and opioids would be expected to
decrease the MAC of ULTANE. The anesthetic requirement for ULTANE is
decreased when administered in combination with nitrous oxide.
ULTANE increases both the intensity and duration of neuromuscular
blockade induced by nondepolarizing muscle relaxants.

Very
rare cases of mild, moderate, and severe postoperative hepatic
dysfunction or hepatitis with or without jaundice have been reported
from postmarketing experiences. In addition, rare postmarketing
reports of hepatic failure and hepatic necrosis have been associated
with the use of ULTANE. Clinical judgment should be used in patients
with underlying hepatic conditions or who are under treatment with
drugs known to cause hepatic dysfunction. It has been reported that
previous exposure to halogenated hydrocarbon anesthetics may
increase the potential for hepatic injury.

INDICATION AND IMPORTANT SAFETY INFORMATION
FOR NIMBEX® (cisatracurium besylate)

INDICATION4

NIMBEX®
(cisatracurium besylate) is an
intermediate-onset/intermediate-duration neuromuscular blocking
agent indicated for inpatients and outpatients as an adjunct to
general anesthesia, to facilitate tracheal intubation, and to
provide skeletal muscle relaxation during surgery or mechanical
ventilation in the ICU.

IMPORTANT SAFETY INFORMATION4

NIMBEX is contraindicated in
patients with known hypersensitivity to the product and its
components. The 10-mL multiple-dose vials of NIMBEX are
contraindicated for use in premature infants because the formulation
contains benzyl alcohol.

Severe anaphylactic reactions to
neuromuscular blocking agents, including NIMBEX, have been reported.
These reactions have in some cases been life-threatening and fatal.
Precaution should be taken in those individuals who have had
previous anaphylactic reactions to other neuromuscular blocking
agents.

NIMBEX should only be administered intravenously in
carefully adjusted dosage by or under the supervision of experienced
clinicians familiar with the drug’s actions and possible
complications.

It is recommended that a peripheral nerve
stimulator be used during the administration of NIMBEX to monitor
drug effect, determine the need for additional doses, and confirm
recovery from neuromuscular block.

NIMBEX has no known
effect on consciousness, pain threshold, or cerebration.

The 10-mL multiple-dose vials of NIMBEX contain benzyl alcohol,
which is potentially toxic when administered locally to neural
tissue. Exposure to excessive amounts of benzyl alcohol has been
associated with toxicity, particularly in preterm infants and
neonates, and there have been rare reports of deaths, primarily in
preterm infants. The minimum amount of benzyl alcohol at which
toxicity may occur is not known. The practitioner must consider the
daily metabolic load of benzyl alcohol from medications containing
this preservative. Single-use vials (5-mL and 20-mL) of NIMBEX do
not contain benzyl alcohol. NIMBEX has not been studied in pediatric
patients below the age of 1 month.

NIMBEX has an
intermediate onset of action and is not recommended for rapid
sequence endotracheal intubation.

NIMBEX will not
counteract the bradycardia produced by many anesthetic agents or by
vagal stimulation.

Doses should be individualized for
conditions causing potentiation of or resistance to neuromuscular
block, such as in patients with neuromuscular diseases, burns,
hemiparesis or paraparesis, acid-base and/or serum electrolyte
abnormalities, and in patients receiving chronic treatment with
phenytoin or carbamazepine.

Long-term infusion (up to 6
days) of NIMBEX during mechanical ventilation in the ICU has been
safely used in 2 studies. Use in the ICU for longer than 6 days has
not been studied. Dosage requirements may increase or decrease with
time. Whenever the use of NIMBEX in the ICU is contemplated, it is
recommended that neuromuscular function be monitored during
administration with a nerve stimulator. Additional doses of NIMBEX
or any other neuromuscular blocking agent should not be given before
there is a definite response to nerve stimulation. If no response is
elicited, infusion administration should be discontinued until a
response returns.

The time to onset of maximum block
following NIMBEX is approximately 2 minutes faster with prior
administration of succinylcholine.

Isoflurane or enflurane
administered with nitrous oxide/oxygen to achieve 1.25 MAC may
prolong the clinically effective duration of action and decrease the
required infusion rate of NIMBEX. Other drugs which may enhance the
neuromuscular blocking action of nondepolarizing agents such as
NIMBEX include certain antibiotics (e.g., aminoglycosides,
tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin,
colistin, and sodium colistemethate), magnesium salts, lithium,
local anesthetics, procainamide, and quinidine.

Adverse experiences were uncommon among the 68 ICU patients who
received NIMBEX in conjunction with other drugs in US and European
clinical studies. One out of 68 patients experienced bronchospasm.
In one study, there were 2 reports of prolonged recovery among 28
patients administered NIMBEX compared with 13 reports among 30
patients administered vecuronium.

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